MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383329

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

Lot #: the customer reported lot # 6077695.However, this lot # does not exist for the reported cat # 383329.(b)(6).Results: a sample or photo was not available for evaluation.We could not confirm the issue at our customer facility with the provided information.Dhr was not consulted because the reported lot number is incorrect.Without lot number, we could not require the certificate of sterility and microbiological tests (pyrogens).Note: this incorrect lot number has already been reported, when the customer reports the lot number correct, one new child will opened for evaluation.Conclusion: we could not found the exactly root cause of the issue since no sample or photo was returned for evaluation.(b)(4).

Event Description

It was reported that patient(s) had superficial reddening/irritation of the skin during use of the 22 g x 0.75 in.Bd saf-t-intima¿ iv catheter safety system.Iv¿s were removed.Some patients were reported to have taken low dose steroids to treat the irritation.

Manufacturer Narrative

Original lot # reported by customer was incorrect.The correct information has been identified as the following: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6277695, medical device expiration date: 2020-09-30, device manufacture date: 2016-10-28, medical device lot #: 5210533, medical device expiration date: 2015-08-06, device manufacture date: 2019-08-31.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Manufacturer Narrative

Investigation: yes, sample received.Actual representative.Three samples were received for evaluation.Two representative samples were received (lot 6277695), sample was reviewed, no foreign matter or contamination was found in the catheter tip or needle tip.One sample was received used (lot 5210533) the sample has a device not manufactured in nogales and the catheter tip shows blood.Dhr for lot number 6277695 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 383329 with lot number 6277695 was manufactured on october 25, 2016.According to sampling plan applied for product performance, this lot was accepted and released.During dhr review the qa tech takes 395 samples to inspect visually, no foreign matter was found in final assembly.During dhr review the qa tech takes 3,250 samples to inspect visually, no defect was found in packaging.Dhr for lot number 5210533 was reviewed and no qns or other events were related to the complaint stated by the customer.Material 383329 with lot number 5210533 was manufactured on august 3, 2015.According to sampling plan applied for product performance, this lot was accepted and released.During dhr review the qa tech takes 290 samples to inspect visually, no foreign matter was found in final assembly.During dhr review the qa tech takes 2,500 samples.Manufacturing review: no equipment, instrument, process and/or surfaces that could cause this kind of reported defect in manufacture.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode investigation comments: after evaluating two representative sample and not find foreign matter in the catheter tip or needle tip, we could not confirm or associate the reported defect to manufacturing process.Used unit it is difficult to find an exactly root cause of this issue; however, the certificate of sterility and microbiological tests (pyrogens) meet with acceptance criteria for both lot numbers 6277695 and 5210533.

• Brand Name: 22 G X 0.75 IN. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6829037
• MDR Text Key: 83937371
• Report Number: 9610847-2017-00060
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K923702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383329
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 08/04/2017; 08/04/2017
• Supplement Dates FDA Received: 12/18/2017; 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other