MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 30ML LL TIP CONV PAK

Catalog Number	305618
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was provided that bd syringe 30ml ll tip conv pak foreign matter it was reported by the customer that in 30 ml syringe, rejected 7 syringes the white material is on the center top of the plunger.Verbatim: 1- (b)(6) brought us rejected syringes from one of the cefazolin 1 g in ns 25 ml syringe batch # 0000521073.If you look at the pictures attached there is white flaky light material which is stuck either on the middle top section of the plunger or right or left side of the plunger.Moreover, there are other type of particles stuck either on the inside wall of the syringe barrel.(b)(6) we will discuss tomorrow about these 30 cc syringe lot, mentioned above.The rejection rate is high (15 in a batch of 100).2- another batch # 0000521105 ceftriaxone 2 g in 20 ml sterile water inj.In 30 ml syringe, rejected 7 syringes, one picture attached at the end.The white material is on the center top of the plunger.Can be seen with zoom in.3- (b)(6) we also need to discuss the previous lot put on hold, where found material on top of the plunger.Testing was done on that syringe by using em plate and no growth was observed.Refer attached e-mail for pictures taken before testing.Additional information: we wanted to complain about 30 cc bd syringes where we are experiencing foreign particles and materials stuck on the plunger.Material item code 305618, lot 4215257.This first one was bad, see first 5 pictures attached.This syringe had foreign material around the neck area of the syringe, on top of the plunger, inside thumb holder area.We put this lot 4215257 on hold.We put the rest of the quantity (590 ea) on hold.(this happened on few weeks back and syringe was not kept.However, pictures were taken) material item code 305618, lot 4305922, we have 15 syringes rejected after filling.See 3 example pictures attached.In a sequence 6, 7, 8.On the plunger area and on the top of plunger a white color flaky material stuck on the plunger.(syringe samples are available).This incident happened couple days back.Material item code 305618, lot 4305922, we have 7 syringes rejected after filling.See reference picture attached at the end.The white material is right on the top of the plunger.We have consumed this lot 4305922 or in filling process.(samples are available).This incident happened couple days back.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 14 photos and 11 physical samples submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that no defects or imperfections were observed.Review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 30ML LL TIP CONV PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21710457
• Report Number: 9610847-2025-00081
• Device Sequence Number: 4656346
• Product Code: FMF
• UDI-Device Identifier: 00382903056187
• UDI-Public: (01)00382903056187(10)4305922
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 305618
• Device Lot Number: 4305922
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown