MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-07-24 for BAG, ENEMA, SLIDE CLAMP, POLYBAG DYND70102 manufactured by Medline Industries, Inc..
[21993473]
It was reported that a pt in the hosp setting was self administering an enema and did not remove the tube tip protector prior to use. When the tube was removed, the protector remained inside. It was subsequently removed in a medical procedure unit. There was no serious injury and the pt did well. This had not been reported to us when the incident first occurred. The tubing is clear and the tip protector is a bright blue color. It is unknown why the end user was self administering this enema and we do not know what instructions were provided by the clinician. No serious injury resulted but medical intervention was required to remove the cap. The incident was not caused by a product defect but rather by misuse on the part of the end user. This is a prescription device and is labeled as such. It is exempt from instructions for use per 21 cfr 801. 109. However, we have taken an additional measure and revised our labeling to add a caution statement indicating the tip protector is to be removed prior to use.
Patient Sequence No: 1, Text Type: N, H10
[22099684]
It was reported that a pt gave himself the enema while on the floor and he left the cap on. When he pulled it out, the cap was retained. It required medical intervention to remove the cap from the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2009-00040 |
| MDR Report Key | 1422397 |
| Report Source | 06 |
| Date Received | 2009-07-24 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-04-01 |
| Date Facility Aware | 2009-07-09 |
| Date Added to Maude | 2010-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAG, ENEMA, SLIDE CLAMP, POLYBAG |
| Generic Name | NONE |
| Product Code | FCE |
| Date Received | 2009-07-24 |
| Model Number | DYND70102 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-24 |