MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-21 for BAG, ENEMA, SLIDE, CLAMP, POLYBAG DYND70102 manufactured by Medline Industries, Inc..
[15006554]
It was reported that a nurse did not remove the tip from the enema tubing and inserted it into a patient. Surgical intervention was required to remove the tip.
Patient Sequence No: 1, Text Type: D, B5
[15171207]
On 3/20/2009 we were made aware of an incident which occurred in (b) (6). It was reported that an enema was to be administered. The tip was not removed by the clinician prior to insertion and initiation of the enema. When the patient complained of pain and unable to tolerate the procedure, the enema tubing was removed and the tip was retained. Surgical intervention was required for removal of the tip. Product from stock was evaluated. The tubing is clear and the protective cap covering the lubricated tubing tip is a bright blue color. The clinician should have known the cap was to be removed. It would have also been noted when the tubing was being primed as the fluid would be coming out around the sides of the cap and not out the end. This is an obvious misuse of the product. This is not a product quality issue but rather a case of misuse. However, due to the report incident requiring surgical intervention, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00028 |
| MDR Report Key | 1368451 |
| Report Source | 06 |
| Date Received | 2009-04-21 |
| Date of Report | 2009-04-16 |
| Date of Event | 2009-02-18 |
| Date Facility Aware | 2009-03-23 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| 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 | 2009-04-21 |
| Model Number | DYND70102 |
| Lot Number | 081808A ZC01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-04-21 |