MAUDE Adverse Event Report: CAREFUSION, INC BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

Model Number 910100

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).Photos available for evaluation.

Event Description

It was reported by the customer that surgeon put a hole in the bottle when he pressed on it with his thumb.Verbatim: surgiphor exploded when surgeon went to press the bottle.His thumb put a hole in the bottle.He was able to duplicate it again with the second bottle.The surgiphor bottle plastic is very rigid and was easily punctured.The saline bottle was very flexible and did not break.This was an orthopedic surgeon trying it for his first time.Either the pvp-i changes the property of the plastic or they use a different plastic for the saline bottle.This has happened to me several times when i have dropped the bottle when in the hospital.It shattered but when i have dropped the saline nothing happened.This was my first case where it was being used during a case that it broke.I have heard of this happening all of the country and not sure why this isn't being addressed.Thank you.On (b)(6) 2022: do you have the lot number? we show this was reported initially for lots possible of 1823044, 1854590.After reviewing their inventory i came to the conclusion it was 1823044.Do you know if either of these lots were in fact affected or was it both of them? where on the bottle was the break, i.E., the cap, or the bottle (container)? if the bottle, was it at the seam? i sent a pix of broken bottle.Bottle ¿ thumb punctured a hole in bottle on both what was the effect on the patient if any? i assume not.Was there a significant procedural delay? possibly delayed the case 10 mins.Was medical intervention required due to the reported issue? no.What was done to complete the irrigation process? used a second bottle and when completed showed how he could put another hole in bottle.It was mentioned that issues have occurred prior when the bottle was dropped.Were those issues previously reported to bd? if so please provide us with the pr complaint file number to reference.Not reported to corp but has happened several times, it had slipped out of pocket and it was maybe 2 feet from the ground.Also yesterday i had one in my bag (out of sterile package) and got a crack in the plastic and leaked all over my bag and papers.To me this is not a good plastic to be using.

Event Description

It was reported by the customer that surgeon put a hole in the bottle when he pressed on it with his thumb.

Manufacturer Narrative

Pr (b)(4) supplemental mdr- a photo was received by our quality team for evaluation.Based, on the photo provided and the review of the customer verbatim, it was determined that complaint is about cracking during use.The lot device history records were reviewed.All process and final inspections meet specifications.A capa has been opened for this issue.An in-depth investigation as part of that capa has been performed to identify the cause of the surgiphor bottle cracking during use.At this time this investigation discovered that the combination of the following variables are probable causes that contribute to the failure mode of surgiphor containers cracking during use: aging, bottle wall thickness/bottle weight, inspected product returned into the manufacturing lot, and upper end of the gamma sterilization dosages of the product.A follow-up will be sent if additional information is received.Section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug) h3 other text : see narrative below.

• Brand Name: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Type of Device: SURGIPHOR
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 15702992
• MDR Text Key: 306978378
• Report Number: 1423507-2022-00018
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1823044
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/15/2022
• Supplement Dates FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other